The application is required according to 35U.S.C. § 119 (e) on 2 12nd, the 2016 U.S. Provisional Patent Application sequences submittedThe benefit of priority of row number 62/294,555, is incorporated herein by reference in their entirety.
Specific implementation mode
Disclosed herein is the system, apparatus and method of the patient for monitoring the chronic disease for suffering from such as heart failure.The system may include biosensor circuit, and signal metric is generated with sense physiological signals and according to physiological signal.The systemIt may include health status analysis circuitry, patient health state (such as heart failure state generated to use signal metricStability) one or more stability indicators.In addition the system can generate instruction patient health state (such as mental and physical effortsFailure progression) one or more health status indicators.Health status indicator and stability indicator next life can be usedDecision is disposed at patient, to provide to the preparation of patient discharge or the instruction for the risk being admitted to hospital.
In the document, using term " hospital ", " being hospitalized ", " being hospitalized again ", " before being hospitalized " or " after being hospitalized ".Although traditionalHospital is the non-limiting example of patient care facility, but these terms should also be envisioned for further relating to any other medical treatment guarantorStrong mechanism or the environment paid close attention to, including urgent care centers, Clinic Nursing center, clinic, special and professional care center, outpatient service handArt center, home health agencies, sanatorium or assisted living house and other short-term or long term care facilities.It is disclosed hereinThe system, apparatus and method for patient monitoring can be used for any one of these health care institutions.
Fig. 1 generally shows the environment that patient management system 100 and patient management system 100 can operate whereinPart example.Patient management system 100 may include flow-type system 105 associated with patient body 102, external systemSystem 125 and the telemetry link 115 that the communication between flow-type system 105 and external system 125 is provided.
Flow-type system 105 may include the treatment of mobile type medical equipment (AMD) 110 and such as lead system 108Delivery system.AMD 110 may include implantable devices, can be implanted in body 102 and via 108 coupling of lead systemClose heart 101.The example of implantable devices can include but is not limited to pacemaker, pacemaker/defibrillator, cardiac resynchronization and controlIt treats (CRT) equipment, heart reconstruction control treatment (RCT) equipment, neuromodulation device, drug delivery device, biological therapy equipment, examineDisconnected equipment or patient monitor etc..AMD 110 can alternately or in addition include be subcutaneously implanted equipment (such as subcutaneous ICD orSubcutaneous diagnostic device), wearable Medical Devices (such as sensor device based on patch) or other exterior monitorings or treatment doctorTreat equipment (such as bedside monitor).
Lead system 108 may include it is one or more through vein, hypodermically or the lead placed of Noninvasive or leadPipe.Each lead or conduit may include one or more electrodes, be adjusted for delivering pace-making, cardioversion, defibrillation, nerveSystem, drug therapy or biological therapy and other kinds for the treatment of.In this example, the electrode on lead system 108 can be determinedAt least part (such as atrium dextrum (RA), right ventricle (RV), atrium sinistrum (LA), left ventricle (LV) or heart of the position in heartBetween part or neighbouring any tissue) inside or surface on.The ability with AMD 110 can be needed to determine based on patientThe arrangement and use of lead system 108 and associated electrode.
AMD 110 can be accommodated for such as by using biosensor or electrode associated with lead system 108Carry out the electronic circuit of sense physiological signals.The example of physiological signal may include electrocardiogram, intra-cardiac electrograms, arrhythmia cordis,Heart rate, heart rate variability, thoracic impedance, intracardiac impedance, angiosthenia, pulmonary artery pressure, left atrial pressure, RV pressure, LV are coronalAngiosthenia, coronary flow temperature, blood oxygen saturation, one or more heart sound, body movement or firmly grade, to movableOne or more of physiological reaction, posture, breathing, weight or body temperature.AMD 110 can based on the physiological signal sensed andInitiation or adjustment for the treatment of.
Patient management system 100 may include state of health monitoring device 160, at least uses and is obtained by flow-type system 105The diagnostic data got provides case control.State of health monitoring device 160 can be supervised with analyzing and diagnosing data for patientDepending on, treatment assessment, risk stratification, when patient such as because deteriorate heart failure and in hospital when patient discharge plan orPatient when patient is not hospitalized or has left hospital is admitted to hospital or readmission's plan.In non-limiting example as shown in Figure 1, it is good forHealth Status Monitor 160 can be substantially comprised in AMD 110.Alternatively, state of health monitoring device 160 can be basicOn be included in external system 125, or be distributed between flow-type system 105 and external system 125.
External system 125 can be used to be programmed AMD 110.External system 125 may include programmable device or troublePerson manages system, from remote location access flow-type system 105 and can monitor patient's states and/or adjustment for the treatment of.It is logicalCross example and unrestricted, and as shown in Figure 1, external system 125 may include external equipment 120 near AMD 110, be inIt is relatively distant from the remote equipment 124 of the position of AMD 110 and links the telecommunication network of external equipment 120 and remote equipment 124122.Telemetry link 115 can be induction telemetry link or radio frequency (RF) telemetry link.Telemetry link 115 can be provided from AMD110 arrive the data transmission of external system 125.This may include, such as, send the non-real time physiological data got by AMD 110,Extraction (such as indicates the rhythm of the heart by the physiological data that AMD 110 is got and is stored in AMD 110, extraction patient history dataThe data of the generation of not normal generation, decompensation and the treatment delivering being recorded in AMD 110), and extract instruction AMDThe data of 110 mode of operation (for example, battery status and lead impedance).Telemetry link 115 can also be provided from external system125 arrive the data transmission of AMD 110.This may include such as, being programmed to AMD 110, with execute obtain physiological data,It executes at least one self diagnosis test (such as operational state), at least one treatment of delivering or analysis and patient is strongOne or more of health state (progress of such as heart failure) associated data.
It can be using any combinations of hardware, software or hardware and software come the part for implementing AMD 110 or external systemSystem 125.The part of AMD 110 either external system 125 can be use can be constructed or be configured to execute one orThe special circuit of multiple specific functions come realize can be either use can be programmed or be additionally configured as execute oneOr the universal circuits of multiple specific functions is realized.This universal circuit may include microprocessor or part of it, micro-Controller or part of it or programmable logic circuit or part of it.For example, inter alia, " comparator " may be used alsoWith including the electronic circuit comparator or the comparator that may be constructed such that the specific comparing function between executing two signalsA part for universal circuit is may be implemented as, the universal circuit can execute two letters by a part for instruction universal circuitThe code of comparison between number drives.
Fig. 2 is generally shown for assessing patient health state and the patient monitoring 200 for disposition risk of being hospitalizedExample.Patient monitoring 200 may include biosensor circuit 210, monitoring mode selector 220, health status analysisOne or more of device circuit 230, user interface 240 and memory 250.At least part of patient monitoring 200 canTo be embodied in AMD 110, be distributed in two or more implantable or wearable Medical Devices, (such as implantable medical is setStandby and subcutaneous Medical Devices) between or be distributed between AMD 110 and external system 125.
Biosensor circuit 210 may include sense amplifier, for sensing indicate inherent physiological activity, whenInduce physiological activity or the physiological activity under other specified requirements one when according to specified stimulation arrangement cardiac stimulusA or multiple physiological signals.Biosensor circuit 210 can be coupled to the one or more such as on lead system 108Electrode, or one or more implantable, wearable or other flow-type biosensors, with the one or more physiology letters of sensingNumber.The example of biosensor may include pressure sensor, flow sensor, impedance transducer, accelerometer, Mike's hearsaySensor, respiration transducer, temperature sensor or blood chemistry sensor etc..The physiology sensed by biosensor circuit 210The example of signal may include electrocardiogram (ECG), electrogram (EGM), thoracic impedance signal, intracardiac impedance signal, angiostheniaSignal, pulmonary arterial pressure signal, RV pressure signals, LV coronary blood pressures signal, coronary flow temperature signal, blood oxygen saturationSignal, central vein pH value, heart sound (HS) signal, postural cue, body movement signal or breath signal etc..Biosensor electricityRoad 210 can be additionally or alternatively coupled to the storage device of storage physiologic information, such as external programmer, electronic health record(EMR) system or memory cell and other data storage devices.
Sense amplifier can handle one or more physiological signals, including for example amplify, digitize, filtering or itsHe operates Signal Regulation.Biosensor circuit 210 can generate one according to handled one or more physiological signalsOr multiple signal metrics.Due to the progression of disease of patient, treatment, drug variation or the variation etc. of posture or activity level, letterNumber measurement can indicate patient health state.In this example, biosensor circuit 210 can be from the electricity on lead system 108Pole receives chest or cardiac impedance signal, and generates the signal metric of the impedance magnitude in designated frequency range.AnotherIn example, biosensor circuit 210 can be sensed from accelerometer, microphone or the acoustics biography for being coupled to AMD 110The HS signals of sensor, and generate two or more HS measurements.The example of HS measurements may include S1, S2, S3 or S4 heart soundThe timing relative to the datum mark of P waves, Q waves or R waves in such as ECG of intensity or S1, S2, S3 or S4 heart sound.In exampleIn, biosensor circuit 210 can receive multiple physiological signals from multiple sensors.For example, biosensor circuit 210 canMay include shrinking to receive the blood pressure signal from pressure sensor and generate two or more blood pressure signals measurementThe timing metric of pressure, diastolic pressure, mean arterial pressure and these pressure measurements relative to datum mark.
Monitoring mode selector 220 can receive the selection between two or more patient monitoring patterns, including patientMonitoring mode after discharge when monitoring mode or patient in hospital when premode of being hospitalized before being admitted to hospital, patient are hospitalized have left hospital.Monitoring mode selector 220 can be coupled to user interface 240, and the user interface 240 may include allowing users toIt inputs to the selection of monitoring mode or be hospitalized user's input of the instruction (for example, patient is hospitalized or discharge) of state of patient is setIt is standby.
Biosensor circuit 210 and monitoring mode selector 220 can be coupled to memory 250.Believed according to physiologyNumber generate signal metric and the selection of monitoring mode can be saved in memory 250.As shown in Fig. 2, memory250 can store the scheduled look-up table or relationship maps for establishing the correspondence between monitoring mode and corresponding signal metric(it is hereinafter referred to as " the specific signal metric of pattern "), for analyzing patient health state.Look-up table or relationship mapsMonitoring mode can be additionally set up with the parameter for being used to handle physiological signal or for the specific signal metric of use pattern to comeAssess the corresponding pass between the algorithm (it is hereinafter collectively referred to as " the specific health status analysis of pattern ") of patient health stateSystem.In this example, parameter (such as sampling frequency for handling physiological signal can be determined based on selected monitoring modeRate, analog-to-digital conversion definition or filter coefficient).In this example, weighting function can be generated and be applied to corresponding letterNumber measurement with generate instruction patient discharge preparation or readmission's risk composite indicator, wherein can be based on selectedMonitoring mode determines weighting function.In another example, it can be used to detect letter to determine based on selected monitoring modeNumber measurement variation degree one or more threshold values or value range.In yet another example, monitoring mode can be based on to selectThe one or more parameters and treatment type of control treatment delivering.Such as discuss that pattern is specifically healthy with reference to figure 4-5 belowThe example of state analysis.
Memory 250 can be with memory state machine comprising various patient monitoring patterns and trigger event that ought be specifiedConversion when occurring or meeting condition between monitoring mode.In this example, monitoring mode selector 220 can be according to being stored inState machine in reservoir 250 and detecting that pattern switching trigger event (such as generates by health status analysis circuitry 230Patient dispose decision) when patient monitoring is switched to the second different monitoring modes from the first monitoring mode automatically.It is all belowThe example of conversion between state machine and monitoring mode is such as discussed with reference to figure 3.
In some instances, health status analysis circuitry 230 may be implemented as a part for microprocessor circuit.It is micro-Processor circuit can be such as digital signal processor, application-specific integrated circuit (ASIC), microprocessor or for include fromThe dedicated processes for the other types of processor that the information for the physiological signal that biosensor circuit 210 receives is handledDevice.Alternatively, microprocessor circuit, which can be, can receive and execute for executing function described here, method or technologyInstruction set general processor.
In some instances, health status analysis circuitry 230 may include include other one or more circuits or sonThe group of circuit (such as 234 circuit of comparator circuit 232 and hybrid circuit).These circuits can execute this paper alone or in combinationFunction, the method or technique of description.In this example, the hardware of circuit group can by immutable be designed as executing specific operation(such as hard-wired).In this example, the hardware of circuit group may include that the physical assemblies changeably connected (such as execute listMember, transistor, ball bearing made etc.) comprising by physically change (for example, magnetically, electrically, be movably disposed it is constantA large amount of particles etc.) to encode the computer-readable medium of the instruction of specific operation.When connecting physical assemblies, hardware compositionBasic electrical characteristics are changed, for example, becoming conductor or vice versa from insulator.These instructions make embedded hardware (such as holdRow unit or load maintainer) it can be specific to execute at runtime via the variable component for connecting establishment circuit group within hardwareThe part of operation.Therefore, when equipment is run, computer-readable medium is communicatively coupled to other groups of circuit group componentPart.In this example, any physical assemblies can be used in the more than one component in more than one circuit group.For example,In operation, execution unit can be used in the first circuit at a time point in the first circuit group, and by firstSecond circuit in circuit group recycles, or place is recycled by the tertiary circuit in second circuit group in different times.
The comparator circuit 232 for being coupled to biosensor circuit 210 and monitoring mode selector 220 can be according to oneA or multiple signal metrics (the specific signal metric of pattern being such as stored in memory 250) generate instruction patient healthThe corresponding stability indicator of corresponding health status indicator and the stability for indicating patient health state.At someIn example, comparator circuit 232 may include the independent circuit for generating health status indicator and stability indicator respectively.ThanIt can be with the specific signal metric of use pattern (X) and corresponding reference levels (X compared with device circuit 232Ref) between comparison generateHealth status indicator.Relative mistake Δ X can indicate the progress of patient health state, such as when patient is not hospitalized (before being hospitalized orLeft hospital) when heart failure deterioration, or when patient is hospitalized heart failure recovery.In this example, comparator circuit 232It can be by X and XRefBetween relative mistake (Δ X) be calculated as such as deviation delta X=X-XRef, or alternatively it is calculated as percentageThan changes delta X=(X-XRef)/XRef.Relative mistake Δ X can be compared with threshold value or specified range to provide health statusIndicator.Health status indicator can be by absolute value (categorical value) or based on relative mistake Δ X and multiple threshold valuesComparison numerical value indicate.
Under the monitoring mode that can be different from current monitoring mode knot can be measured using multiple history of signal metric XFruit determines reference levels XRef.In this example, with reference to XRefCan be in hospital before baseline, being determined to be in patient does not have mental and physical effortsThe average value of multiple measurement results of signal metric X between the early period of being hospitalized of failure decompensation or other object events, intermediate value or itsHis central tendency index (central tendency index).In another example, when thinking that patient is extensive from target diseaseWhen keeping stablizing in redoubling and at the appointed time section, with reference to XRefCan be that signal metric X is lived specified be hospitalized duringInstitute's baseline level.Reference levels XRefIt can be stored in memory 250.
In relative mistake (the Δ X) under calculating the first monitoring mode, comparator circuit 232 can be used monitors mould firstThe one or more signal metrics obtained during formula and the corresponding reference levels (X corresponding to the second different monitoring modesRef)。For example, when being hospitalized because of Worsening heart failure as patient and being monitored under monitoring mode in hospital, comparator circuit 232 canSo that used in the specific signal metric of pattern obtained during monitoring mode of being hospitalized and baseline level X before corresponding be hospitalizedRefBetweenComparison come generate instruction heart failure restore health status indicator.In another example, after patient has left hospitalAnd it is monitored under monitoring mode after discharge, comparator circuit 232 can use to be obtained during monitoring mode after dischargeThe specific signal metric of pattern and baseline level X in hospitalRefBetween comparison come generate instruction Worsening heart failure health statusIndicator.
In addition to or instead of the specific signal metric of pattern (X) and corresponding reference levels (XRef) between relative mistake, compareDevice circuit 232 can be based on the variation of signal metric during the first monitoring mode or rate of change and the second different monitoring modesComparison between the variation or rate of change of period signal metric generates health status indicator.For example, as patient because of the heartForce failure deteriorate and in hospital when, comparator circuit 232 can determine the specific signal metric of pattern (X) during hospital stays sectionVariation or rate of change by this variation or rate of change and lead to the identical signal degree during the preceding period of being hospitalized in hospitalThe corresponding variation or rate of change of amount are compared, and the variation or variation of the signal metric during monitoring mode of being hospitalizedThe variation of X or when the interior specified range (margin) of rate of change during monitoring mode before rate is fallen into hospital, generates healthy shapeState indicator.
Comparator circuit 232 can use one or more specific signal metrics of pattern during patient monitoring patternThe variability of (such as about 1-14 hours or 1-7 days) generates stability indicator in the specified period.Variability is shownExample may include range, interquartile range, percentile spacing, standard deviation, variance, coefficient of variation, degree of skewness or histogramFigure or deviation are estimated.Stability indicator can such as variation of the specific signal metric of pattern based on one or moreProperty indicated by the numerical value of absolute value or such as stability score with the comparisons of various threshold values.In this example, filter circuit can be withFilter coefficient including the circadian rhythm variation for being selected as one or more physiological signals that decaying senses.According to through filterTherefore the variability for the signal metric that the physiological signal of wave generates may be influenced smaller by the variation of the circadian rhythm of physiological signal.The stability indicator of the obtained specific signal metric of pattern can more reliably reflect the stability of patient health state.
Hybrid circuit 234 can be coupled to comparator circuit 232, and can use health status indicator and stabilizationProperty indicator come generate patient dispose decision.Patient, which disposes decision, can indicate that patient is admitted to hospital or the preparation of readmission or dischargeRisk.It can be related with the stability of patient health state to the associated stability indicators of signal metric X.This patient is steadyOtherwise qualitative information may not appear in health status indicator (such as relative mistake Δ X).Stability in use indicator canTo reduce the possibility of unsuitable patient's disposition, such as patient leaves hospital too early or certain patients are unnecessary is hospitalized again.CauseThis, can be provided using the patient monitoring of both health status indicator and stability indicator to patient health stateThe more accurate assessment of (progress of such as chronic disease), and therefore more reliable disposition decision is provided.
Patient dispose decision can be based on respectively meet corresponding condition (such as when signal metric X and it is corresponding refer to waterFlat XRefBetween relative mistake drop below specified progress threshold value and signal metric X variability drop below it is specifiedVariability threshold value when) health status indicator and stability indicator.In this example, as patient because of the heart failure deterioratedExhaust and in hospital when, the Xin Haoduliang | of S3 intensities of heart sounds;|S3||And other signal metrics can be used to monitor in hospital to assessPatient restores.Ji Yu ||S3||Disposition score DS||S3||, (1) Zhu Yuan | can be based on;|S3||With the preceding Ji Xian | that is hospitalized;|S3||RefBetween relative mistake, and (2) be hospitalized the | that is hospitalized during pattern;|S3||Stability (such as across it is multiple be hospitalized ||S3||Measure knotFruit ||S3||Variability (var (s ||S3||))) and generate.Ru Guo ||S3||Ji Xianshuiping | before being reduced in hospital;|S3||RefSpecified range, and var (s ||S3||)) fall below threshold value, then DS||S3||Score is " 1 ", is based on Xin Haoduliang ||S3||Indicate the preparation of patient discharge.If health status indicator or stability indicator fail to meet corresponding condition,DS||S3||Score is " 0 ", indicates the unripe discharge of patient.That is,
Wherein T1And T2Indicate ||S3||Relative mistake and ||S3||Variability corresponding threshold value.In this example, threshold valueT1Can be about 10%.In this example, threshold value T2Can be about 10%.In another example, threshold value T2Can be about40%.
In some instances, hybrid circuit 234, which can use, corresponds to all one or more signal metric (such as { X(i) }={ X (1), X (2) ..., X (N) } wherein N indicates the quantity of signal metric) in some health status indicators and steadyThe combination of qualitative indicator disposes decision to generate patient.It is (all that hybrid circuit 234 can be based on corresponding health status indicatorSuch as relative mistake Δ X (i)) and corresponding stability indicator (such as, variability estimates var (X (i))) and be directed to each signalEstimate X (i) and generates corresponding disposition score DS (i).Disposition score DS (i) can be based on the evidence of signal metric X (i) and indicateWith patient's disposition (such as patient is hospitalized, discharge or readmission) associated risk.{ DS (i) } (corresponds to signal metric { X(i) } combination) may include linearly or nonlinearly combining.In this example, hybrid circuit 234 can use the linear of { DS (i) }Weighted array generates compound disposition score cDS:
Wherein wiIndicate the weighted factor of DS (i).It can be based on the corresponding signal degree during particular patient monitoring modeThe signal of amount X (i) using or signal characteristic determine weighting function wi.In this example, before patient is hospitalized, if for inspectionThe HF for the deterioration for causing patient to be hospitalized is surveyed, signal metric X (i) is used but another signal metric X (j) is not used, then is being livedLarger weight w during institute's patterniIt can be applied to DS (i), and smaller weight wj(wj<wi) DS can be applied to(j).In another example, before patient is hospitalized, if signal metric X (i) is causing HF decompensations event and patient to be hospitalizedPeriod during show variation more deeper than another signal metric X (j) and be applied to DS then during pattern in hospital(i) weight wiThe weight w for being applied to DS (j) can be more thanj.In this example, including ||S3||, thorax impedance (Z), shallow exhale soonThe multiple signal metrics for inhaling index (RSBI) and heart rate (HR) be used to monitor in hospital to assess patient from the mental and physical efforts caused in hospitalThe recovery of failure event.Hybrid circuit 234 can generate cDS:CDS=w1·DS||S3||+w2·DSZ+w3·DSRSBI+w4·DSHR, wherein w1To w4Indicate the weighted factor of corresponding progress score.If the HF of the preceding detection , | that is hospitalized to(for) deterioration;|S3||It is used with Z and RSBI and HR are not used or Ru Guo ||S3||It is respectively shown with Z ratio RSBI and HR more significantLead to variation in hospital, then w1And w2It is likely larger than w3And w4.In this example, w1=w2=1, and w3=w4=0.5.Mixing electricityRoad 234 can alternatively be counted by using decision tree, neural network, fuzzy logic model or multivariate regression models etc.Calculate the nonlinear combination of disposition score.
Although individual DS (i) is based on the evidence provided by signal metric X (i) and indicates wind associated with patient's dispositionDanger, but compound disposition score cDS can provide the comprehensive assessment pair dispose associated risk with patient.For example, largerCDS can indicate from by patient be switched to it is different be hospitalized state or monitoring modes it is associated compared with low-risk, such as make patientLeave hospital or patient is made to be admitted to hospital.In this example, if cDS is more than threshold value or falls into specified range, hybrid circuit 234 can give birth toDecision is disposed at patient.Example thresholds may be about 1.5.In this example, if corresponding to the compound place for monitoring mode of being hospitalizedIt sets score and meets discharge standard, then hybrid circuit 234 can generate patient's disposition decision of the preparation of instruction patient discharge.AnotherIn one example, if meeting readmission's standard corresponding to the compound disposition score of monitoring mode after discharge, hybrid circuit 234 canPatient to generate the risk that instruction patient is admitted to hospital again disposes decision.Hybrid circuit 234 can be coupled to memory 250 withStorage includes that disposition score (DS (i)), compound disposition score cDS and the patient disposition of signal metric are determined in memory 250The information of plan.
User interface 240 may include the output unit of user input equipment and such as display.In this example, userAt least part (such as output unit) at interface 240 may be implemented in external system 125.The example of input equipment can be withIncluding keyboard, mouse, trace ball, touch tablet, touch screen or other directions or navigation equipment on keyboard, screen.User inputsEquipment can be coupled to biosensor circuit 210, so that system user can be to being used for one of sense physiological signalsOr multiple parameters are programmed.User input equipment may be coupled to monitoring mode selector 220, can receive such asThe user command of monitoring mode is selected in monitoring mode after premode in hospital, be hospitalized monitoring mode and discharge.In this example,Monitoring mode selector 220 can be based on state machine, existing patient monitoring pattern and can trigger to be converted to different patient's prisonsIt automatically determines whether to be switched to different trouble depending on the event (patient such as generated by hybrid circuit 234 disposes decision) of patternPerson's monitoring mode.User command may include such as based on patient discharge or being admitted to hospital and confirming or change to the automatic of monitoring modeSelection.
Output unit can be generated disposes decision and the presentation of shown human-perceivable over the display to patient.It is defeatedGo out unit can also show including by biosensor circuits sense to physiological signal and the signal that is generated according to physiological signalMeasurement, health status indicator associated with signal metric and stability indicator, equipment state (such as lead impedance and completeWhole property), the information of battery status (remaining life of battery) or heart capture threshold value etc..Output unit can also be shownMultiple selectable patient monitoring patterns and the current selection to patient monitoring pattern.Information can with table, chart, figure orText, table or the graphical representation format of any other type are presented to be shown to system user.It can to the presentation of output informationTo include audio or the appreciable media formats of other mankind, with warning system user from a patient monitoring Mode change to anotherOne different patient monitoring pattern.
In some instances, patient monitoring 200 can also comprise treatment circuit, be configured as such as in response toStability indicator, health status indicator or patient dispose one or more of decision and deliver and treat to patient.TreatmentExample may include being delivered to heart, nerve fiber or other destination organizations in response to the detection to desired physiological eventElectronic stimulation, or the drug therapy including delivering the medicament to tissue or organ.In some instances, stability indicatesSymbol, health status indicator or patient, which dispose decision, can be used to change existing treatment (such as adjusting stimulation parameter or drugDosage).
Fig. 3 generally shows Figure 30 0 of the transformation of the state between two or more patient monitoring patterns, can beSuch as it is stored in the embodiment of the state machine in memory 250.It is unrestricted by example, and as shown in figure 3, state machine can be withIncluding monitoring mode (M before being hospitalizedPreH) 310, be hospitalized monitoring mode (MH) 320 and discharge after monitoring mode (MPostH)330.WithAssociated each monitoring mode includes one or more specific signal metrics of pattern (one in such as 312,322 or 332)And one or more health status analysis parameters (one in such as 314,324 or 334).The specific signal metric of pattern andHealth status analysis parameter can be stored in memory 250, and can be by health status analysis circuit 230 for determiningPatient health state including health status indicator and stability indicator, and dispose decision for generating patient.
Signal metric associated with a monitoring mode can be different from signal degree associated with another monitoring modeAmount.In this example, not associated with another monitoring mode with the associated at least one signal metric of a monitoring mode.ShowingIn example, at least one signal metric can be shared by two different patient monitoring patterns.In some instances, can according to fromThe physiological signal that identical biosensor senses generates signal metric associated with the first monitoring mode and is supervised with secondDepending on the associated another signal metric (but differing from each other) of pattern.For example, being believed according to the heart sound sensed from heart sound transducerNumber and generate S1 intensity of heart sounds (s ||S1||) signal metric can be used for monitoring mode M in hospitalH, but be consequently not used forInstitute premode MPreH, and the S3 intensity of heart sounds (s | generated according to cardiechema signals using identical heart sound transducer;|S3||) can be withIt is included in premode M in hospitalPreHIn, but be not included in monitoring mode M in hospitalHIn.
It can be based on about ambient enviroment, patient body or health status, the physiology sensing for wherein using biosensorDevice selects the information of the sensitivity of the progress of patient health state etc. the response or signal metric of certain types for the treatment ofSelect the specific signal metric of pattern for corresponding patient monitoring pattern.For example, based on patient than being hospitalized during being hospitalizedMore sluggish information, characterization body movement (such as activity intensity, frequency or duration) or profit on preceding or rear body of being hospitalizedWith the information about body movement (such as to movable physiological reaction, PRA or based between body movement and other physiological parametersCorrelation signal metric) signal metric can be excluded with monitoring mode M in hospitalHWhat associated pattern was specifiedExcept signal metric 322;However, it is this can be included in the relevant signal metric of body movement respectively be hospitalized before or go outAfter institute in the associated signal metric of monitoring mode 312 or 332.In another example, Sui Ran ||S3||It potentially contributes to detectIt may lead to the event of HF decompensations in hospital, but compared to such as thorax impedance (Z) or S1 Xin Yinqiangdus ||S1||Other letterNumber measurement, may be less sensitive to the changes of acute hemodynamics of certain patients, or smaller to the reaction of hospital acute treatment.Therefore, Sui Ran ||S3||In signal metric 312 before being included in hospital during monitoring, but in the monitoring Qi Jian | that is hospitalized;|S1||Or Z may may ||S3||It is more suitable, and therefore can be included in signal metric 322.Can additionally or substituteGround is based on the target disease or illness to be monitored (such as heart failure, pulmonary edema, chronic obstructive pulmonary disease (COPD), pneumonia, the heartMuscle infarction, dilated cardiomyopathy (DCM), ischemic cardiomyopathy, valvular heart disease, nephrosis, peripheral vascular disease, cranial vascular disease, liverDisease, diabetes, anaemia, depression, pulmonary hypertension, sleep disordered breathing, hyperlipidemia etc.) carry out the specific signal of selection modeMeasurement.
Health status analysis parameter 314,324 and 334 may include for handling physiological signal or generating signal metricParameter, sample frequency, analog-to-digital conversion definition or filter coefficient etc..Health status analysis parameter can also comprise useDispose in one or more threshold values of the variation degree of detection signal metric or applied to patient the weighting function or such as of scoreIt is used by hybrid circuit 234 to generate the linearly or nonlinearly combinational algorithm of compound disposition score and disposition decision.
From the first monitoring mode to the transformation of the second different monitoring modes can by pattern switching trigger event (such as byThe patient that hybrid circuit 234 generates disposes decision) triggering.As previously discussed, item is specified when compound disposition score cDS meetsWhen part (such as cDS is more than threshold value), preparation of being such as hospitalized can be generated, patient's disposition that discharge prepares or readmission prepares is determinedPlan.As shown in figure 3, preparing decision in response to being hospitalized for being generated at hybrid circuit 234, the monitoring mode before being hospitalized can be establishedTo the transformation 351 of monitoring mode in hospital.It can prepare decision in response to discharge and establish after monitoring mode to discharge in hospital and superviseDepending on the transformation 352 of pattern.It can prepare decision in response to readmission and establish after discharge monitoring mode to monitoring mode in hospitalTransformation 353.Monitoring mode selector 220 can automatically or additionally be based at least partially on user's input, according to stateMachine Figure 30 0 executes patient monitoring pattern switching.
Fig. 4 generally shows the example for disposing the health status analysis circuitry 400 of decision for generating patient, canTo be the embodiment of health status analysis circuitry 230 as shown in Figure 2.Health status analysis circuitry 400 may include ratioCan be the comparator circuit 232 and mixing electricity of health status analysis circuitry 230 compared with device circuit 430 and hybrid circuit 440The corresponding embodiment on road 234.Health status analysis circuitry 400 can also include signal metric selector circuit 410 or rawManage functional analysis device circuit 420.In some instances, health status analysis circuitry 400 may be implemented as microprocessor electricity(such as digital signal processor, application-specific integrated circuit (ASIC), microprocessor can receive and execute execution to the part on roadThe general processor of functions described herein, the instruction set of method or technique).
Signal metric selector circuit 410 can be according to selected monitoring mode and from one or more signal metricsThe specific signal metric of the one or more patterns of selection.It can be according to the look-up table or relationship maps being stored in memory 250Carry out the specific signal metric of selection mode, the look-up table or relationship maps establish monitoring mode and for signal processing or patientsCorrespondence between corresponding signal metric or parameter that health status uses.Signal metric selector circuit 410 can be with needleIn addition select one or more of physiological function analysis circuitry 420 physiological function analyzer to be suitable for analysis accordinglyThe mutually deserved signal metric collection of physiological function.By unrestricted example, and as shown in figure 4, physiological function analyzer electricityRoad 420 may include one or more in cardiac functional analysis device 422, renal function analyzer 424 or pulmonary function analyser 426 etc.It is a.It can be different from and select for another physiological function analyzer for the signal metric of physiological function analyzer selectionSignal metric, it is different such as at least one signal metric.In this example, two or more physiological functions point can be directed toParser and selection signal are measured.For the signal metric ({ X of cardiac functional analysis device 422C(i) }={ XC(1), XC(2) ...,XC(N) } example) may include heart rate, heart rate variability, the morphological feature extracted from ECG or electrogram, thoracic impedance,Pulmonary arterial pressure, activity level, posture, S1 intensities of heart sounds, S3 intensities of heart sounds, shrink fixed time interval or penetrate before blood and ejection time,Ventricular pressure or pulmonary arterial pressure etc..For the signal metric ({ X of renal function analyzer 424R(j) }={ XR(1), XR(2) ..., XR(M) } example) may include creatinine level, body urea nitrogen (BUN) level, BUN/ creatinines ratio or glomerular filtration rate(GFR) etc..For the signal metric ({ X of pulmonary function analyser 426P(k) }={ XP(1), XP(2) ..., XP(K) } example)May include respiratory rate, Rapid-shallow-breathing index, tidal volume, thorax impedance, heart sound, heart rate or pulmonary arterial pressure etc..
Each physiological function analysis circuitry can be using the specific signal metric of corresponding pattern come in specified patientThe corresponding instruction to particular physiological function is generated during monitoring mode.It can be wrapped for example, cardiac functional analysis device 422 can generateInclude cardiac function indicator (such as signal metric X of cardiac function progressC(i) with reference levels XC-Ref(i) relative mistake Δ XC(i)) and heart stability indicator (such as during particular patient monitoring mode in special time period XC(i) variationProperty is estimated).Similarly, renal function analyzer 424 can generate may include renal function progress indicator renal function indicator(such as signal metric XR(j) with reference levels XR-Ref(j) relative mistake Δ XRAnd kidney stability indicator (such as X (j))R(j) variability is estimated).Similarly, pulmonary function analyser 426 can generate may include lung function progress indicator lung work(It can indicator (such as signal metric XP(k) with reference levels XP-Ref(k) relative mistake Δ XP(k)) and lung stability indicatesAccord with (such as XP(k) variability is estimated).Can use obtained during different from the monitoring mode of current monitoring mode it is moreA historical measurement respectively determines reference levels XC-Ref(i),XR-Ref(j) and XP-Ref(k)。
Heart can be used by being coupled to the comparator circuit 430 of various physiological function analysis circuitries 422,424 and 425One or more of role indicator, renal function indicator or lung function indicator refer to generate one or more health statusShow symbol and one or more stability indicators.In this example, health status indicator can be cardiac function progress indicator,The polymerization of one or more of renal function progress indicator and lung function progress indicator is linearly or nonlinearly combined.ShowingIn example, stability indicator can be cardiac function stability indicator, stable renal function indicator and lung function stabilityThe polymerization of one or more of indicator is linearly or nonlinearly combined.Monitor and analyze multiple physiological function (such as heartsDirty function, lung function or renal function), the comprehensive assessment to patient health state (progress of such as chronic disease) can be provided.Disposition decision based on multiple physiological functions can reduce unsuitable patient disposition and (such as discharge too early or unnecessary reenterInstitute) possibility.Multiple physiological functions may be utilized for the validity for determining treatment plan or particular treatment, or guidance is controlledTreat the titration (titration) of type or dosage.It is related to one or more of physiological function analyzer 422,424 and 426The progress indicator and stability indicator of connection and the combination health status indicator provided by comparator circuit 430 or combinationStability indicator can be stored in memory 250, and/or be present in the display of user interface 240.
Hybrid circuit 440 can use the health status indicator and stability that are such as provided by comparator circuit 430 to refer toShow symbol and disposes decision to generate patient.Similar to hybrid circuit 234 as shown in Figure 2, hybrid circuit 440, which can be directed to heart, to be believedNumber measurement { XC(i) }, kidney signal metric { XROr lung signal metric { X (j) }POne or more of (k) } corresponding disposition is generatedScore DSC(i),DSR(j) or DSP(k).Disposition score can be based on respectively meeting the relative mistake of specified requirements (for example, Δ XC(i),ΔXR(j) or Δ XP(k)) estimate (for example, var (X with variabilityC(i)),var(XROr var (X (j))P(k))).ShowingIn example, hybrid circuit 440 can generate the compound disposition score of multiple physiological function instructions, and such as cardiac function instruction is compoundDispose score cDSC, renal function instruction compound disposition score cDSROr the compound disposition score cDS of renal function instructionR.It can be with{ X is measured using corresponding to N number of heart signalCSome or all of (i) } combination of disposition score calculates cDSC.It is similarGround can use and correspond to M kidney signal metric { XRSome or all of (j) } combination of disposition score calculates cDSR,And it can use and correspond to K lung signal index { XPSome or all of (k) } combination of disposition score calculatescDSP.In this example, which can be linear weighted combination, shown in such as following equation (3):
Similar to the discussion with reference to the hybrid circuit 234 in figure 2, weighting function wi,wjIt can be each based on particular patient with wkThe signal of corresponding signal metric during monitoring mode using or signal characteristic determine.
Compound disposition score (such as cDS of physiological function instructionC,cDSRAnd cDSP) user interface 240 can be present inDisplay on, and be stored in memory 250.As the risk DS (i) based on signal metric and between comprehensive cDSThe by-level of risk assessment, particular physiological function of the compound disposition score based on patient of physiological function instruction is (for example, the heartDirty, kidney or lung function) it can respectively indicate risk associated with patient's disposition decision.Suffer from when being monitored according to particular monitored patternWhen person, the compound disposition score of physiological function instruction can be additionally used for diagnosing commodity or titration treatment.Physiology can be combinedIt is some or all of to generate patient's disposition decision in the compound disposition score of function instruction.In this example, if cDSC,cDSRAnd cDSPIt is more than respectively that in the range of the threshold value that respectively specifies that or fall into respectively specifies that, then can generate the standard of such as patient dischargeStandby or readmission's risk patient's disposition.In this example, hybrid circuit 440 can calculate cDSC,cDSRAnd cDSPCombination it is (allSuch as linear weighted combination):
CDS=α1·cDSC+α2·cDSR+α3·DSp (4)
Wherein, weighted factor a1To a3Can each free user to be based on patient health state or target disease specified or adjust.For example, if patient is hospitalized because pulmonary edema deteriorates, it in hospital can be by the weight a of bigger since pulmonary edema deteriorates3It answersIt, then can be by the weight a of bigger for the disposition score DS of lung function-instruction3Disposition score applied to lung function-instructionDSp, this is because may play a decisive role in the preparation of assessment patient discharge to the instruction that lung function is restored.Show anotherIn example, if patient is hospitalized because of HF decompensations, weight a1,a2And a3It can substantially be equally weighted, because of the heartThe recovery of dirty, kidney and lung function all plays an important role in the preparation for determining patient discharge.If cDS is more than specified thresholdOr fall within the specified range, then it can make disposition decision.
In some instances, health status analysis circuitry 400 can be coupled to be configured as delivering to patient and treatTreatment circuit.It in response to stability indicator, health status indicator or specified requirements can be met (such as falls into specified takeBe worth in range) patient dispose one or more of decision and deliver treatment.The example for the treatment of may include electronic stimulationOr drug therapy etc..
Fig. 5 generally illustrates another example of patient monitoring 500, can be patient monitoring system as shown in Figure 2The embodiment of system 200.Patient monitoring 500 may include biosensor circuit 510, monitoring mode selector 220, healthOne or more of state analyzer circuit 230, user interface 240 and memory 250.As biosensor circuit 210Embodiment biosensor circuit 510 may include parameter adjuster circuit 512, sense amplifier 514 and filteringDevice circuit 516.Sense amplifier 514 may include for being carried out to the physiological signal sensed with specified sampling rateThe sample circuit of sampling, and for making the digitized analog-digital converter of the physiological signal sensed with specified ADC resolution ratio(ADC).Filter circuit 516 can execute the filtering to physiological signal using one or more analog or digital filters,One or more of analog or digital filters, which respectively have, determines the specified of cutoff frequency and passband or stopband characteristicFilter coefficient.
One can be adjusted by being coupled to the parameter adjuster circuit 512 of sense amplifier 514 and filter circuit 516A or multiple parameters (such as ADC resolution ratio, sampling rate or filter coefficient).As shown in figure 5, parameter adjuster circuit 512Monitoring mode selector 220 and memory 250 can be coupled to.From corresponding to different patient monitoring patterns signal sampling,Digitizing or filter associated signal processing parameter can be such as in the form of look-up table, relationship maps or other data structureIt is stored in memory 250.Parameter adjuster circuit 512 can receive selected monitoring from monitoring mode selector 220Pattern, and corresponding signal processing parameter is determined according to the look-up table or relationship maps that are stored in memory 250.GinsengNumber adjuster circuit 512 may be coupled to user interface 240 to receive such as confirming or changing signal processing parameterOne or more of user command.In this example, sampling rate can change from the 200Hz in a monitoring mode to another100Hz in the monitoring mode of one selection.In another example, sampling rate can be from daily 100 in a monitoring modeIt is secondary to change to daily 20 times in the monitoring mode of another selection.
In this example, in response to the selection to monitoring mode of being hospitalized, sense amplifier 514 can be used according to oneOr variation or rate of change of multiple physiological signals in the designated time period before being hospitalized and the sampling rate determined are feltSurvey one or more physiological signals.For example, if before being hospitalized physiological signal or the signal degree by its production during monitoring modeAmount significantly change (for example, within the specified time before patient is admitted to hospital signal intensity or rate of change drop to specified threshold withUnder), then signal or signal metric can be used to monitor patient health state during monitoring mode in hospital.In this example, firmlyThe sampling rate of physiological signal during institute's monitoring mode can to signal be hospitalized before variation or rate of change it is proportional so thatLower sampling rate can be applied to show the signal of deeper front signal variation of being hospitalized.The notable change of signal strengthChange or rate of change can be with indication signals to the higher sensitivity of patient health state change so that can use more sensitive passSensor more easily detects patient health state change.Lower sampling rate can not damage detection patient health stateData volume is reduced in the case of the sensitivity of variation and saves storage space.In another example, sampling rate can with liveInstitute's front signal variation or rate of change are inversely proportional so that can be applied to higher sampling rate to show deeper be hospitalizedThe signal of front signal variation.The significant changes or rate of change of signal strength can be indicated for detecting patient to hospitalizationThe higher reliability of the signal of response.Higher sampling rate can ensure that the change for reliably and accurately detecting patient health stateChange.Biosensor circuit 510 can generate one or more signal metrics according to processed physiological signal, can be by being good for230 use of health state analyzer circuit is for analysis patient health state and generates patient's disposition decision.
Fig. 6 is generally illustrated for using patient monitoring (such as patient monitoring shown in Fig. 2 and Fig. 4 respectivelySystem 200 or 400) come monitor patient method 600 example.Method 600 can mobile type medical equipment (AMD) (includingSuch as implantable or wearable Medical Devices), the programmable device for being programmed to AMD, with AMD communicate or be distributed in AMD andIt is carried out in patient management system between external system and is executable wherein.In this example, method 600 can be by suffering fromPerson's monitoring system 200 or its any modification execute.
Method 600 can at the step 610 by two or more patient monitoring patterns (its may include in hospital beforePattern (MPreH), be hospitalized monitoring mode (MH) or discharge after monitoring mode (MPostH)) between selected and started.Enter in patientBefore institute, M can be usedPreH.When patient is just hospitalized, M can be usedH.When patient has left hospital, M can be usedPostH.Such as Fig. 2Shown, monitoring mode can be by user (such as clinician) via the user input equipment for being such as coupled to user interface 240To select.
At 620, one or more physiological signals can be such as sensed by using corresponding biosensor.PhysiologySignal can indicate the reaction of inherent physiological activity or the induction to stimulation or other external disturbances.The example of physiological signal can be withIncluding electrocardiogram (ECG), electrogram (EGM), thoracic impedance signal, intracardiac impedance signal, arterial pressure signal, pulmonary arterial pressure letterNumber, RV pressure signals, LV coronary blood pressures signal, coronary flow temperature signal, oxygen saturation signal, central vein pHValue, heart sound (HS) signal, postural cue, body movement signal or breath signal etc..
Physiological signal can be by processing (including amplification, digitlization, filtering or other Signal Regulations operate).In this example,Parameter (such as sample frequency, analog-to-digital conversion point for handling physiological signal can be determined based on selected monitoring modeResolution or filter coefficient).In this example, it during monitoring mode in hospital, can use according to physiological signal before being hospitalizedDesignated time period in variation or rate of change and the sampling rate determined carrys out sense physiological signals.For example, if livingPhysiological signal or the signal metric by its production significantly change (for example, specified before patient is admitted to hospital during monitoring mode before instituteSignal intensity or rate of change drop to specified threshold or less in time), then signal or signal metric can be used to be hospitalizedPatient health state is monitored during monitoring mode.In this example, the sampling rate of the physiological signal during monitoring mode can in hospitalWith to signal be hospitalized before variation or rate of change it is proportional.In another example, sampling rate can become with front signal in hospitalChange or rate of change is inversely proportional.In this example, adjustment parameter (such as sample frequency, analog-to-digital conversion definition or filter are used forCoefficient) method can be carried out and be executed by it in biosensor circuit 510 as shown in Figure 5 or its any modification.
At 630, one or more signal metrics can be generated according to processed one or more physiological signals.SignalMeasurement can be the statistics or morphological feature extracted from physiological signal, and can indicate the progression of disease due to patient, controlPatient health state caused by treatment, drug variation or variation of posture or activity level etc..The example of signal metric can beHeart rate, heart rate variability, cardiomotility timing (cardiac activation timing), the form from ECG or EGM are specialSign, the impedance magnitude in designated frequency range, the intensity of S1, S2, S3 or S4 heart sound or timing, diastolic pressure, are averagely moved systolic pressurePulse pressure or pressure measure the timing etc. relative to datum mark.
It in some instances, can be from the one or more signal degree corresponding to particular monitored pattern generated at 630The subset of the specific signal metric of selection mode in amount.Correspondence between monitoring mode and the specific signal metric of pattern canTo be established and be stored in such as memory 250.It can be based on about ambient enviroment, the patient for wherein using biosensorBody or health status, biosensor are to the response or signal metric of certain types for the treatment of to patient health stateThe information of the sensitivity of progress etc. selects the specific signal metric of pattern for corresponding patient monitoring pattern.It is supervised with oneSignal metric associated with another monitoring mode is can be different from depending on the associated signal metric of pattern.In this example, with oneA associated at least one signal metric of monitoring mode is not associated with another monitoring mode.In this example, at least one letterNumber measurement can be shared by two different patient monitoring patterns.It in some instances, can be according to from identical biosensorThe physiological signal that senses generates signal metric associated with the first monitoring mode and associated with the second monitoring modeAnother signal metric (but differing from each other)
At 640, one or more signal metrics can be directed to and generate corresponding health status indicator and corresponding steadyQualitative indicator.Health status indicator indicates patient health state, and stability indicator indicates patient health stateStability.It can be calculated as the corresponding reference levels (X of X corresponding to the health status indicator of signal metric XRef) between phaseTo poor Δ X.Reference levels XRefIt can be determined that the baseline of the X under the particular monitored pattern different from current monitoring modeValue.In this example, with reference to XRefCan be in hospital before baseline, be determined to be in patient do not have heart failure decompensation or otherAverage value, intermediate value or other central tendency indexes of multiple historical measurement X between early period of being hospitalized when object event.AnotherIn one example, when thinking patient from recovery in target disease and keeping stablizing in section at the appointed time, with reference to XRefIt can be withIt is in the specified baseline of being hospitalized determined during being hospitalized.X and XRefBetween relative mistake (Δ X) deviation delta X can be calculated as=X-XRef, or alternatively it is calculated as percentage changes delta X=(X-XRef)/XRef.It can be by relative mistake Δ X and threshold valueOr specified range is compared to provide health status indicator.
Alternatively, can based on the variation of signal metric during the first monitoring mode or rate of change from differentThe variation of signal metric or the comparison of rate of change determine health status indicator during second monitoring mode.For example, when suffering fromPerson because Worsening heart failure and in hospital when, it may be determined that the hospital stays section during signal metric X variation or rate of change,And by its with the corresponding variation of same signal metric or rate of change are compared during the period before leading to being hospitalized in hospital.Before if in hospital, the variation of signal metric or rate of change are fallen in hospital during monitoring mode during monitoring mode X variationOr in the specified range of rate of change, then health status indicator can be generated.
Stability indicator may include the specific signal metric of one or more patterns during patient monitoring patternVariability in the specified period.The example of variability may include range, interquartile range, percentile spacing, markQuasi- deviation, variance, coefficient of variation, the degree of bias or histogram or deviation are estimated.In this example, physiological signal can be carried outFiltering, the circadian rhythm rhythm and pace of moving things to remove or in deamplification so that calculated variability will be by the physiology of physiological signalTempo variation influences smaller.
At 650, it can use and one or more signal metrics { X (i) }={ X for particular monitored model selection(1), X (2) ..., X (N) } at least some of corresponding health status indicator and stability indicator generate patientDispose decision.Patient disposes decision and can indicate the preparation of patient discharge or be admitted to hospital or the risk of readmission.In this example, forEach signal metric X (i), can be based on corresponding health status indicator (such as relative mistake Δ X (i)) and corresponding stabilityIndicator (such as variability estimates var (X (i))) disposes score DS (i) accordingly to generate, in such as above equation (1)Shown disposition score DS||S3||.Disposition score DS (i) can based on signal metric X (i) evidence and indicate and patient dispose phaseAssociated risk.Stability in use indicator can reduce inappropriate patient and dispose (such as too early patient discharge or certain patientsUnnecessary readmission) possibility so that obtained patient disposes decision and can provide to patient health state (such asThe progress of heart failure) more acurrate and more reliable assessment.
Then compound disposition score cDS can be calculated as to the combination of { DS (i) } corresponding with signal metric { X (i) }.Although independent DS (i) is based only on the evidence provided by signal metric X (i) and indicates risk associated with patient's disposition,Comprehensive assessment pair dispose associated risk with patient can be provided by being compound disposition score cDS.In this example, such as aboveEquation (2) shown in, cDS can be the linear weighted combination of { DS (i) }.It can be based on during particular patient monitoring modeThe signal of corresponding signal metric X (i) using or signal characteristic determine the weighting function applied to DS (i).For example, if signalMeasure ||S3||It is used before patient is hospitalized, and than another during the period for causing HF decompensations and patient to be hospitalizedThe signal metric of Rapid-shallow-breathing index (RSBI) shows deeper variation, then during monitoring of being hospitalized, is applied toDS||S3||Weight can be more than be applied to DS||RSBI||Weight.In another example, can such as by using decision tree,Neural network, fuzzy logic model or multivariate regression models etc. and the nonlinear combination that cDS is calculated as to { DS (i) }.If cDSIt more than threshold value or falls into specified range, then can generate patient and dispose decision.
At 660, the presentation that patient disposes the human-perceivable of decision can be generated and be presented on such as user interfaceIn display in 240.Alternately or in addition, it can be presented other information, including physiological signal, be generated according to physiological signalSignal metric, health status indicator associated with signal metric and stability indicator, equipment state, selectable troubleThe current selection etc. of person's monitoring mode or patient monitoring pattern.Information can be with table, chart, figure or any other typeText, table or graphical representation format are presented to be shown to system user.Presentation to output information may include audio or itsThe appreciable media formats of his mankind are supervised with warning system user from a patient monitoring Mode change to another different patientDepending on pattern.
In some instances, patient's disposition decision can be used to current patents' monitoring mode being automatically switched to anotherDifferent monitoring modes.State machine based on all state machines as shown in Figure 3 and the information about current patents' monitoring mode, patientDisposition decision can be used to trigger monitoring mode switch.For example, can be established before being hospitalized in response to being hospitalized preparation decisionMonitoring mode can prepare decision to establish from monitoring mode in hospital to discharge to the conversion for monitoring mode of being hospitalized in response to dischargeThe conversion of monitoring mode afterwards, or decision can be prepared in response to readmission and monitored to establish the monitoring mode after discharge to being hospitalizedThe conversion of pattern.
In some instances, patient monitoring 200 can also comprise such as in response to stability indicator, healthy shapeState indicator or patient dispose one or more of decision and deliver and treat to patient.The example for the treatment of may include in response toIt is delivered to the electronic stimulation of heart, nerve fiber or other destination organizations to the detection of desired physiological event, or includingDeliver the medicament to the drug therapy of tissue or organ.In some instances, stability indicator, health status indicator or troublePerson, which disposes decision, can be used to change existing treatment (such as adjusting stimulation parameter or drug dose).
Fig. 7 is generally shown for being analyzed based on physiological function and generates the example that patient disposes the method 700 of decision.(it can be the step 640 and 650 of Fig. 6 for generating status indicator, stability indicator and disposition decision to method 700Specific embodiment) can be carried out or be executed by it in health status analysis circuitry 400 or its any modification.
At 710, according to the one or more signal metrics generated at 630, one or more specific signal degree of patternAmount can be selected respectively, to be carried out to two or more physiological functions (cardiac function, renal function or lung function etc.)Analysis.It can be different from the letter that selection is analyzed for another physiological function for the signal metric that a physiological function analyzes selectionNumber measurement is different such as at least one signal metric.In this example, two or more physiological functions can be directed to analyzeDevice and selection signal are measured.For the signal metric ({ X of cardiac functional analysisC(i) } example may include heart rate, heart rate changeIt is anisotropic, strong from ECG or the morphological feature of electrogram extraction, thoracic impedance, pulmonary arterial pressure, activity level, posture, S1 heart soundDegree, S3 intensities of heart sounds are shunk fixed time interval or are penetrated before blood and ejection time, ventricular pressure or pulmonary arterial pressure etc..For renal function pointThe signal metric ({ X of analysisR(j) } example may include creatinine level, body urea nitrogen (BUN) horizontal, BUN/ creatinines ratio orGlomerular filtration rate (GFR) etc..For the signal metric ({ X of analysis of Pulmonary FunctionP(k) }=example may include respiratory rate, it is shallowFast spiro-index, tidal volume, thorax impedance, heart sound, heart rate or pulmonary arterial pressure etc..
Then, the selected signal metric { X at 720AC(i) } it can be used to generate corresponding cardiac function instructionSymbol and heart stability indicator.Similarly, at 720B, selected signal metric { XR(j) } can be used to generate phaseThe renal function indicator and kidney stability indicator answered, and at 720C, selected signal metric { XP(k) } can by withIn the corresponding lung function indicator of generation and lung stability indicator.Similar to the status indicator and stability at the 640 of Fig. 6Indicator generates, with XC(i),XR(j) or XP(k) associated particular physiological function indicator can be calculated as signal metricRelative mistake between reference levels, and heart stability indicator can be calculated as signal metric and be monitored in particular patientVariability in the period of finger during pattern.
At 730A, cardiac function instruction can be calculated based on cardiac function indicator and heart stability indicatorCompound disposition score cDSC.In this example, cDSCCan be and signal metric { XCSome or all of (i) } corresponding placeSet the combination of score.Similarly, it can be used at 730B and signal metric { XRSome or all of (j) } corresponding placeThe combination of score is set to calculate the compound disposition score cDS of renal function instructionR, and can use at 730C and signal metric{XPSome or all of (k) } combination of corresponding disposition score calculates the compound disposition score cDS of lung function instructionP。In this example, it is all as in equation shown in, which can be linear weighted combination.
At 740, compound disposition score (such as cDS of physiological function instructionC,cDSRAnd cDSPSome or all of)Compound disposition score cDS can be combined to generate, cDS shown in such as equation (4)C,cDSRAnd cDSPWeighted array.If cDS is more than specified threshold or falls within the specified range, disposition decision can be made.In another example, if cDSC,cDSRAnd cDSPIt is more than respectively that in the range of the threshold value that respectively specifies that or fall into respectively specifies that, then can generate patient's disposition.In addition toExcept other information, patient, which disposes decision, at 660 can be presented to system user.
Detailed description above includes to which constitute the references of the attached drawing of a part for detailed description.It is attached by explanationSpecific embodiments of the present invention can be implemented by showing.These embodiments are also referred to herein as " example ".These examples can be withInclude in addition to shown or described element other than those.However, the present inventor, which has been additionally contemplates that, wherein provides only thoseThe example of shown and described element.In addition, for particular example (or one or more in terms of), or just institute hereFor other examples (or in terms of one or more) show or described, the present inventor also contemplates using shownOr the arbitrary example combined or arrange of those described elements (or in terms of one or more).
If the use between this document and any document being incorporated to by reference is inconsistent, in the documentSubject to use.
It is different from the usage of any other situation or "at least one" or " one or more " in the document, such as existEither "one" is used to common term " one " includes one or more than one in patent document.In the document,Term "or" be used to refer to non-exclusionism alternatively, to which " A or B " include " A but be non-B ", " B but be non-A " and " A and B ",Unless otherwise specified.In the document, term " comprising " and " wherein " are used as the simplicity of corresponding term "comprising" and " wherein "English equivalents.In addition, in the following claims, term " comprising " and "comprising" are open, that is to say, thatAfter this term in the claims it is those of listed other than system, equipment, product, composition, preparation orPerson includes that element process is still considered within the scope of the claims.In addition, in the following claims, term " theOne ", " second " and " third " etc. are used only as marking, and do not have numerical requirements to its object.
Method example as described herein can be machine implementation or computer-implemented at least partly.Some examples can be withThere are the computer-readable medium or machine readable media of instruction, described instruction to be operable to configure electronics including codingEquipment executes the method in above-mentioned example.The implementation of this method may include such as microcode, assembler language code, advancedThis code of language codes etc..This code may include can be with reading instruction for executing the computer of various methods.CodeIt may be constructed a part for computer program product.In addition, such as during execution or at other times, code can be tangibleGround is stored in one or more volatibility or non-volatile tangible computer and can read on medium.These tangible computers can be withThe example for reading medium may include but be not limited to hard disk, mobile hard disk, removable CD (such as compact disk and digital videoDisk), cassette, storage card or memory stick, random access memory (RAM), read-only memory (ROM) etc..
Above description is merely exemplary, and not restrictive.For example, above-mentioned example (or in terms of one or more) canWith in combination with one another.Such as those skilled in the art can use other implementations if having read above descriptionExample.Abstract is provided according to 37C.F.R. § 1.72 (b), to allow reader to quickly determine essence disclosed in the technology.It should be understood thatBe it be not used in explanation or limit claims range or meaning.It, can will be various in addition, in discussed in detail aboveFeature is combined open to simplify.This open feature for being not construed as meaning to be not claimed wants any rightSeeking Truth is necessary.On the contrary, subject matter can be less than whole features of disclosed specific embodiment.Thus, it weighs belowProfit requires to be incorporated at this in detailed description using as example or embodiment, wherein each claim itself represents the present inventionIndividual embodiment, and be additionally contemplates that this embodiment can with it is various combination or arrangement be combined with each other.The scope of the present inventionIt should be determined with reference to whole equivalency ranges of appended claims and these claims.